1550nm Non-ablative Fractional Vs 1927nm Thulium Fractional Laser for the Treatment of Female Pattern Hair Loss

NCT06926023 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: Hair-1550-vs-1927
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy of either a 1550nm non-ablative fractional laser or a 1927nm thulium fractional laser in the treatment of female pattern hair loss (FPHL).

Conditions

Female Pattern Baldness

Outcome Measures

Primary Outcomes (3)

• Change in hair count at a predefined 1cm x 1cm scalp location

  Measured by the Canfield Hair Matrix System

  Baseline and Day 180

• Change in hair density (hairs/cm) at the same predefined scalp area

  Measured by the Canfield Hair Matrix System

  Baseline and Day 180

• Change in terminal hair average diameter (in mm) at the predefined location

  Measured by the Canfield Hair Matrix System

  Baseline and Day 180

Secondary Outcomes (5)

• Change in Sinclair Scale score

  Baseline and Day 180

• Change in perceived age based on blinded evaluator assessment of global scalp photographs

  Baseline and Day 180

• Subjective Assessment on Hair outcomes

  Day 180

• Physician Global Aesthetic Improvement Scale (PGAIS) via photos by blinded evaluator

  Day 180

• Comfort Level Visual Analog Scale

  Baseline, Day 30, Day 60, Day 90

Study Arms (2)

GROUP A 1550nm non-ablative fractional laser

EXPERIMENTAL

Group A: Study subjects will have a total of 4 treatments spaced 4 weeks apart. No additional topical treatments applied

Device: 1550nm non-ablative fractional laser

GROUP B 1927 thulium fractional laser

ACTIVE COMPARATOR

Group B: Study subjects will have a total of 4 treatments spaced 4 weeks apart. No additional topical treatments applied.

Device: 1927 thulium fractional laser

Interventions

1550nm non-ablative fractional laser DEVICE

Treatment with the 1550nm non-ablative fractional laser for female pattern hair loss to the frontal and crown of scalp.

GROUP A 1550nm non-ablative fractional laser

1927 thulium fractional laser DEVICE

Treatment with the 1927 thulium fractional laser for female pattern hair loss to the frontal and crown of scalp.

GROUP B 1927 thulium fractional laser

Eligibility Criteria

• Age: 35 Years - 65 Years
• Gender Eligibility Details: Gender Identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult women aged 35-65 years
• Fitzpatrick skin types I-IV
• Presence of female pattern hair loss of the frontal or vertex of scalp (Sinclair (II-IV)
• Must be willing and can comply with all study protocols, including all treatment schedules, follow up visit, assessments, sign a photography release and ICF, and complete the entire course of the study
• Patients with gray hair roots must be willing to dye their gray hair within two weeks of the first appointment and the last 3-month follow-up visit to ensure consistency in evaluator assessments.
• No use of hair growth treatments or procedures within 6 months prior to enrollment (including hair supplements such as Nutrafol)
• Subjects in good general health based on investigator's judgment and medical history
• Negative urine pregnancy test result at the time of study entry
• Subjects will be of non-childbearing potential defined as:
• Having no uterus
• No menses for at least 12 months.
• Or;
• Subjects of childbearing potential must agree to use an effective method of birth control during the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment participation. Acceptable forms of birth control below:
• Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device
• Intrauterine coil

You may not qualify if:

• No surgery, pregnancy, breast feeding, change in or addition of hormonal contraception in the last 6 months
• No history of iron deficiency anemia, vitamin D deficiency, or thyroid disease (hypothyroidism or hyperthyroidism or currently on thyroid supplementation)
• Use of scalp light or with laser treatment within the last 6 months.
• Use of topical or systemic drugs affecting hair growth within 6 months prior to enrollment (such as oral spironolactone, finasteride, oral or topical minoxidil, and supplements marketed for hair growth such as Nutrafol)
• Supplementation of oral tumeric/curcumin
• History of hair transplant
• Systemic or scalp disease that may affect hair growth (Lupus, alopecia areata, folliculitis decalvans, psoriasis, scalp infection, seborrheic dermatitis, CCCA, telogen effluvium)
• Pregnancy or planned pregnancy during the study or currently breastfeeding.
• Any uncontrolled systemic disease
• History of autoimmune connective tissue disease or thyroid disease.
• Current use of immunosuppressive medication.
• Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
• Active dermatitis, metal or other active implants, active infection in the proposed treatment area.
• Subjects with scarring in the treatment areas (scalp) Subjects with a history of keloids will be excluded.
• History of bleeding disorder, concomitant use of anticoagulants, history of connective tissue disease, history of Bell's Palsy, epilepsy, smoking, pregnancy, and lactation.

Sponsors & Collaborators

• Goldman, Butterwick, Fitzpatrick and Groff: lead

Study Sites (1)

West Dermatology Research Center/Cosmetic Laser Dermatology

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Andrea Pacheco

CONTACT

858-657-1004; apacheco@clderm.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Evaluator Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 13, 2025
• Study Start: May 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

US (1)